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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE ALLERGIST TRAY W/ BD PRECISIONGLIDE¿ PERMANENTLY ATTACHED NEEDLE ALLERGY SYRINGE AND NEEDLE

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BD MEDICAL - DIABETES CARE ALLERGIST TRAY W/ BD PRECISIONGLIDE¿ PERMANENTLY ATTACHED NEEDLE ALLERGY SYRINGE AND NEEDLE Back to Search Results
Catalog Number 305540
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/06/2018
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that while reaching into a tray of allergist tray w/ bd precisionglide¿ permanently attached needle one of the staff at asthma sinus allergy program at gbm was pricked by a needle that had been poked through the plastic safety cap. Found before use. No reports of serious injury or medical intervention noted.
 
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Brand NameALLERGIST TRAY W/ BD PRECISIONGLIDE¿ PERMANENTLY ATTACHED NEEDLE
Type of DeviceALLERGY SYRINGE AND NEEDLE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer (Section G)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7643035
MDR Text Key112561702
Report Number1920898-2018-00445
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Medical Assistant
Type of Report Initial,Followup
Report Date 07/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305540
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/27/2018 Patient Sequence Number: 1
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